The GME TwinScan 808/755 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.

The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-VI).

Device Description

The TwinScan 808/755 Laser System is a diode laser designed to be used in Dermatological practice for stable, long term hair reduction.

The TwinScan 808/755 Laser System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner. The device may be configured with 808 nm or 755 nm Applicators, in two treatment area sizes, at the factory. The TwinScan 808/755 Laser System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the TwinScan 808/755 Laser System.

Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore (in this case, hair follicle). Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

AI/ML Overview

I am sorry, but the provided text does not contain information on the acceptance criteria and a study that proves the device meets those criteria. The document is an FDA 510(k) premarket notification for the "TwinScan 808/755 Laser System", primarily focusing on establishing substantial equivalence to predicate devices. It lists device specifications and indications for use, but does not detail acceptance criteria or specific clinical study results for device performance against those criteria. It only mentions that performance data was submitted, specifically "Testing reports for IEC 60825-1 and IEC 60601-2-22" and "IEC 60601-1 and IEC 60601-1-2", which refer to international safety standards for laser products and medical electrical equipment. These are not clinical studies demonstrating the effectiveness of the hair removal or permanent hair reduction claims.

Therefore, I cannot provide the requested table or detailed information regarding sample sizes, ground truth, expert qualifications, or MRMC studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 19, 2019

GME German Medical Engineering GmbH % Mike Johnson Consultant Philosopher's River LLC P O Box 106 Willow Creek, Montana 59760

Re: K192269

Trade/Device Name: TwinScan 808/755 Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: August 6, 2019 Received: August 21, 2019

Dear Mike Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Purva Pandva Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192269

Device Name TwinScan 808/755 Laser System

Indications for Use (Describe)

The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-V).

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K192269

510(k) Summarv

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 08-08-2019 [21 CFR 807.92(a)(1)].

A. Applicant Name and Address [21 CFR 807.92(a)(1)]

GME German Medical Engineering GmbH.

Grimmstrasse 23

Germany 90491

Tel: +49 9131 934159 10

Fax: +49 9131 934159 99

B. Contact Information

Philosopher's River Ilc

P O Box 106

Willow Creek, MT 59760

Tel: 406-209-3039

Fax: 406 209 3039

Contact person: Mike Johnson M.D.

mike@philosophersriver.com

C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name: TwinScan 808/755 Laser System Device Common Name: Laser Instrument for Dermatology Classification Name: Laser Instrument, Surgical Powered 21 CFR 878.4810 Product Code: GEX Device Classification: Class II

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D. Predicate Devices [21 CFR 807.92(a)(3)]

The TwinScan 808/755 Laser System uses similar technology and physical output characteristics as the following predicate devices: K180518 GME LinScan Lite 808 System, and K143519 Asclepion MeDioStar NEXT

E. Device Description [21 CFR 807.92(a)(4)]

The TwinScan 808/755 Laser System is a diode laser designed to be used in Dermatological practice for stable, long term hair reduction.

F. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)]

The GME TwinScan 808/755 Laser System is compared to the predicates

· GME LinScan Lite 808 System K180518
· Asclepion MeDioStar K143519

The indications for use and classification for the TwinScan 808/755 Laser System are equivalent to the predicates. Below is a comparison table of specifications.

Characteristic	GME TwinScan 808/755Laser System	GME LinScan Lite 808Laser System	Asclepion MeDioStarNeXT PRO XL
	"TwinScan"	"LinScan 808"	"MeDioStar"
Applicable510(k)s	NA	K180518	K143519

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Panel/	General and PlasticSurgery	General and Plastic Surgery	General and PlasticSurgery
Product Code/RegulationNumber	GEX21 CFR 878.4810	GEX21 CFR 878.4810	GEX21 CFR 878.4810
Indications forUse Statement	The GME TwinScan808/755 Laser System isindicated for hair removaland permanent hairreduction defined as thestable, long-term reductionin hair counts at 6, 9, or 12months following atreatment regime.The GME TwinScan808/755 Laser System isintended to be used on allskin types(Fitzpatrick I-VI).	The GME LinScan Lite 808Laser System is indicatedfor hair removal andpermanent hair reductiondefined as the stable, long-term reduction in hair countsat 6, 9, or 12 monthsfollowing a treatmentregime.The GME LinScan Lite 808System is intended to beused on all skin types(Fitzpatrick I-VI).	The MeDioStar NeXTFamily laser system isintended for hair removaland permanent hairreduction defined asreduced hair growth withor without maintenancewhen measured at 6, 9 and12 months.The MeDioStar NeXTFamily laser system isintended for the treatmentof benign vascular lesions.The MeDioStar NeXTFamily laser system isintended for the treatmentof benign pigmentedlesions.
Classification	Class IV	Class IV	Class IV
Common Name	Pulsed diode laser	Pulsed diode laser	Pulsed diode laser
Mechanism ofAction	Heats chromophores(pigments) and water in theskin through the absorptionof light. The heatingdenatures proteins of thehair follicle	Heats chromophores(pigments) and water in theskin through the absorptionof light. The heatingdenatures proteins of thehair follicle.	Heats chromophores(pigments) and water inthe skin through theabsorption of light. Theheating denatures proteinsof the hair follicle.

Characteristic	GME TwinScan 808/755Laser System"TwinScan"	GME LinScan Lite808"LinScan Lite 808"	Asclepion MeDioStarNeXT PRO XL"MeDioStar"
Applicable510(k)s	NA	K180518	K143519
Mode ofOperation	Pulsed diode laser	Pulsed diode laser	Pulsed diode laser
Light Source	Laser diode	Laser diode	Laser diode
Light Delivery	Laser and scanner are in theApplicator handpiece	Laser and scanner are inthe Applicator handpiece	Laser is in handpiece
Cooling of Skin	Sapphire provides contactcooling	Sapphire providescontact cooling.	Sapphire provides contactcooling.
Treatment AreaSize	f-hp - applicator:15 x 13 mm,15 x 50 mm or 15 x 25 mmp-hp - applicator:10 x 25 mm, 10 x 13 mm	10 x 25 mm, 10 x 13mm	14 x 10 mm.4 x 3 mm,8 x 6 mm,30 x 10 mm,38 x 24 mm
Peak Power	Up to 300 W	Up to 150W	2400W
Power Density	See wavelength comparison	See wavelengthcomparison	See wavelength comparison
Fluence(Energy Densityper Flash)	See wavelength comparison	See wavelengthcomparison	See wavelength comparison
Pulse Duration	4-100ms	4-100ms	Up to 400ms
Repetition Rate	up to 10 Hz	up to 2 Hz	4 to 12 Hz
System Cooling	Self contained, closed watercirculation system	Self contained, closedwater circulation system	Self contained, closedwater circulation system
Wavelength	755 nm or 808 nm	808 nm	755 nm, 808 nmor 940 nm
Beam Mode	Multimode	Multimode	Multimode
Aiming Beam	None	None	None
Controls	Footswitch or handswitch	Footswitch orhandswitch	Footswitch or handswitch
ElectricalRequirements	100 V-240 V @ 50/60 Hz,max.1750 W	100V-240V @ 50/60Hz,max. 900W	100 -240 VAC, 50/60 Hz,max. 1500W
PowerCalibrationMethod	Diode current calibrated byexternal power ruler	Diode current calibratedby external power ruler	Diode current calibrated byexternal power ruler
SterilizationAspects	Applicator is cleaned /disinfected between patients.	Applicator is cleaned /disinfected between patients.	Applicator is cleaned /disinfected between patients.
Pulse Formation	CW current switched on / off	CW current switched on / off	CW current switched on / off
Pulse TrainDuration	4 ms – 100 ms	4 ms – 100 ms	Up to 400 ms
Beam Diameter	f-hp applicator:1mm x 15mmp-hp applicator:0.75 mm x 10 mm	0.75 mm x 10 mm	14 x 10 mm,4 x 3 mm,8 x 6 mm,30 x 10 mm,38 x 24 mm
Duty Cycle	< 100%	< 100%	< 100%
Pulse Controls	fluence, pulse duration	fluence, pulse duration	fluence, pulse duration
Display	Touch Screen Control Panel	Touch Screen Control Panel	Touch Screen Control Panel

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Characteristic	GME TwinScan808/755 LaserSystem"TwinScan"	GME LinScan Lite808"LinScan 808"	Asclepion MeDioStarNeXT PRO XL"MeDioStar"
Applicable 510(k)s	NA	K180518	K143519
808 nm Predicate		X
808 Beam Size	f-hp applicator:1mm x 15mm (0.15 cm2)p-hp applicator:0.75 mm x 10 mm(0.075 cm2)	0.75 mm x 10 mm	NA
808 Power Density	Up to 2000 W/cm²	Up to 2000 W/cm²	NA
808 Treatment AreaSize	f-hp – 808 applicator:15 x 13 mm (1.95 cm2)15 x 25 mm (3.75 cm2)15 x 50 mm (7.5 cm2)p-hp - 808 applicator:10 x 25 mm (2.5 cm2)10 x 13 mm (1.3 cm2)	10 x 13 mm10 x 25 mm	NA

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808 Peak Power	Up to 300 W	Up to 150W	NA
808 Fluence	4-100 J/cm²	4-100 J/cm²	NA
755 Predicate		NA	X
755 Beam Size	f-hp applicator:1mm x 15mm(0.15 cm²)p-hp applicator:0.75 mm x 10 mm(0.075 cm²)	NA	1.4 cm²
755 Power Density	f-hp = 150W/0.15cm²=1000 W/cm²p-hp = 75W/0.075= 1000 W/cm²	NA	ALX handpiece2400W/1.4cm²=1714 W/cm²
755 Treatment AreaSize	f-hp – 755 applicator:15 x 13 mm (1.95 cm²)15 x 25 mm (3.75 cm²)15 x 50 mm (7.5 cm²)p-hp - 755 applicator:10 x 25 mm (2.5 cm²)10 x 13 mm (1.3 cm²)	NA	1.4 cm²
755 Peak Power	Up to 150 W	NA	2400W
755 Fluence	4-50 J/cm²	NA	Up to 35 J/cm²

G. Indications for Use [21 CFR 807.92(a)(5)]

The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-VI).

H. Performance Data [21 CFR 807.92(b)(2)]

The Guidance Document, Laser Products – Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice 56) January 19, 2018 was used. Testing reports for IEC 60825-1 and IEC 60601-2-22 were submitted. Testing reports for IEC 60601-1 and

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IEC 60601-1-2 were also submitted.

I. Conclusion [21 CFR 807.92(b)(3)]

The GME TwinScan 808/755 Laser System is substantially equivalent to the predicate devices, the GME LinScan Lite 808 System and Asclepion MeDioStar; in terms of technology, function and indications for use. There are no new questions of safety or efficacy raised by the introduction of the TwinScan 808/755 Laser System.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.